We have reviewed the claim of categorical exclusion under 21 CFR 25.32(i) for the above referenced notification and have found that the categorical exclusion is warranted.

As we reviewed this claim, we considered whether the labels or tapes to which the subject substances will be added can be called finished food-packaging material as is necessary if the categorical exclusion in §25.32(i) is to apply. It is certainly clear to us that the potential for significant environmental impacts from the use and disposal of components of labels and tapes applied directly to foods is essentially identical to the potential for impacts associated with the class of actions that warrant exclusion under §25.32(i). But it is not entirely clear that labels and tapes that are applied directly to food can be called food-packaging material.

As a part of this review, we looked at the record for recent petitions and found that the agency had amended its regulation in response to two petitions, FAP 9B4663 and FAP 9B4678, for substances listed in 21 CFR 175.125. This section is for pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes applied to food. The records for FAP 9B4663 and FAP 9B4678 show that these two petitioners had each claimed the categorical exclusion under §25.32(i) and that these claims had been accepted. Since these two actions were approved after review by the Office of Chief Counsel, it is now clear to us that the labels and tapes applied directly to foods can be considered food-packaging material for the purpose of the categorical exclusion in §25.32(i).

The claim of categorical exclusion cites the section under which the categorical exclusion is claimed, includes a statement of compliance with the categorical exclusion criteria, and includes a statement that no extraordinary circumstances exist that require submission of an environmental assessment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Please let us know if there is any change in the identity or use of the food-contact substance.